Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Alphatec HoldingsLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Alphatec Manufacturing with 20 510(k) clearances. The most recent is a 510(k) clearance dated Mar 26, 2004: ICON POLYAXIAL PEDICLE SCREW SYSTEM.
| Mar 26, 2004 | ICON POLYAXIAL PEDICLE SCREW SYSTEMK033090 · KWP | 510(k) clearances |
| Dec 11, 2002 | ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEMK023299 · MNI | 510(k) clearances |
| Jul 23, 2002 | ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEMK020356 · MNH | 510(k) clearances |
| Apr 26, 2000 | DELTALOC ANTERIOR CERVICAL PLATE SYSTEMK993513 · KWQ | 510(k) clearances |
| Jan 3, 2000 | ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION RODK993873 · KTT | 510(k) clearances |
| Sep 22, 1999 | PYLON INTRAMEDULLAARY NAIL SYSTEMK992350 · HSB | 510(k) clearances |
| May 22, 1998 | ALPHATEC WIRE EXTERNAL FIXATION SYSTEMK980788 · JDW | 510(k) clearances |
| Apr 28, 1997 | ALPHATEC EXTERNAL FIXATION SYSTEMK964400 · KTT | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
